New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:

08/11/2005

Trade Name:

Mobic

Generic Name or Proper Name (*):

meloxicam

Indications Studied:

Relief of signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis

Label Changes Summary:

* Safety and efficacy established in patients 2 years of age and older * Clinical studies evaluated doses ranging from 0.125 mg/kg/day to 0.375 mg/kg/day. There was no additional benefit demonstrated by doses above 0.125 mg/kg/day in the clinical trials. The lowest effective dose should be used * Adverse events in children were similar to those in adults including skin reactions and gastrointestinal bleed risk * Information on dose, PK parameters, AE profile and clinical studies